Reconstitution With Pimecrolimus Cream 1% of Steroid-damaged Skin in Adults With Atopic Dermatitis

Phase 4

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: Pimecrolimus cream 1%

• Registration Number: NCT00367393
• Lead Sponsor: Novartis

Brief Summary

Topical steroid use may lead to skin deterioration and spider veins. This study will examine long-term management of atopic dermatitis (AD) over 12 months with pimecrolimus cream 1% and its effect on skin reconstitution of steroid-damaged skin and disease control.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-08-21
• Study First Submitted QC: 2006-08-21
• Study First Posted: 2006-08-22
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• clinically diagnosed AD
• almost clear to mild AD (local IGA [target lesions face and cubital areas] score of 1-3)
• clinically (i.e. to the unaided eye) evident skin atrophy due to long-term topical steroid use
• Dermatophot Score (DPS - composed of skin atrophy and telangiectasia) of 4-6 on at least two target areas

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Exclusion Criteria

• Phototherapy or systemic therapy known or suspected to have an effect on AD within 4 weeks prior to study entry
• Topical therapy known or suspected to have an effect on AD within 7 days prior to study entry or systemic corticosteroids within 4 weeks prior to study entry
• Clinical conditions other than AD that according to investigator can interfere with the Dermatophot evaluation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Pimecrolimus cream 1%	Pimecrolimus cream 1%

Primary Outcome Measures

Name	Time	Method
• Decrease of the Dermatophot (a combination of a dermatoscope and a camera) score on skin deterioration and spider veins from baseline to end of the study	48 weeks

Secondary Outcome Measures

Name	Time	Method
Skin metabolism by suction blisters.	48 weeks
• Epidermal thickness by optical coherence tomography at selected investigational centers	48 weeks
Skin thickness by ultrasound at selected investigational centers	48 weeks
Epidermal thickness by 3mm punch biopsies (optional)	48 weeks
Investigator's Global Assessment (IGA)	48 weeks

Trial Locations

Locations (1)

Novartis; 🇩🇪 Novartis, Germany